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Methods for Analyzing the Modified Rankin Scale in Stroke Thrombolysis Trials: A Systematic Review and Methodological
Sisong Cheng1, Mingzhen Qin1,2, Peipei Du1
1Department of Neurology, Dongzhimen Hospital Beijing University of Chinese Medicine Beijing China.
Journal of the American Heart Association
|April 22, 2026
Summary
Heterogeneity in modified Rankin Scale (mRS) analysis methods complicates thrombolysis trial results. A common mRS score of 0-1 is insufficient; a new framework is proposed for better stroke outcome analysis.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- Modified Rankin Scale (mRS) analysis methodologies in intravenous thrombolysis trials show significant heterogeneity.
- This compromises the interpretation and comparability of trial results.
- Reevaluation of contemporary mRS analysis is needed for clarity and future trial design.
Purpose of the Study:
- To comprehensively reevaluate current mRS analysis methodologies in intravenous thrombolysis trials.
- To clarify findings from existing studies.
- To provide insights for optimizing future clinical trial designs.
Main Methods:
- Systematic literature search of PubMed, Embase, and Cochrane Library for randomized controlled trials (RCTs) on intravenous thrombolysis in acute ischemic stroke.
- Studies focused on 90-day mRS as the primary outcome.
- Adherence to PRISMA and STAIR XI guidelines for screening, risk-of-bias assessment, and data extraction.
Main Results:
- 38 RCTs (n=30,470) were included; 5 had moderate risk of bias.
- A 90-day mRS score of 0-1 was the most frequent primary outcome (57.9%).
- Trials with mild/moderate, younger, or male-dominant populations favored mRS 0-1; those with moderate/severe, older, or female-dominant populations favored ordinal shift analysis.
Conclusions:
- Significant variation exists in primary outcome selection for intravenous thrombolysis trials.
- The common 90-day mRS score of 0-1 is inadequate for diverse patient populations.
- A proposed 3-dimensional framework integrating stratified outcomes and methodological rigor can advance mRS analysis in stroke thrombolysis research.
